Clinical Trial of Transtek Body Fat Analyzer (GBF-1251-B & Other 3 Models) (BS-BT)

Verify the Functions and Efficiency of Transtek (Trade Mark) Body Fat Analyzer, GBF-1251-B, BF-1255-B, BF-1256-B, and GBF-1257-B

The clinical protocol of the clinical testing of this device:

1. Objective of the test: To verify the functions and efficiency of devices.
2. Test methods and procedures: Comparison Test.
3. Device Under Test (DUT): Transtek Body Fat Analyzer, Model: GBF-1251-B, BF-1255-B, BF-1256-B, and GBF-1257-B.
4. Comparison device: Transtek, Glass Body Fat Analyzer, GBF-950-D.
5. Study endpoints: DUT and the comparison device are substantial equivalence.
6. Statistical methodology used: Description of statistical methods.

Study Overview

• Status: Completed
• Conditions: Weight; Body Fat Disorder; Bone Mass
• Intervention / Treatment: Device: Transtek 125X; Device: Transtek 950D

Detailed Description

1. Test Purpose:

   The aim of clinical test is to collect weight, body fat, total body water, bone mass, and muscle mass reading value which measured by DUT and reference device.

2. Target Subject:

   The subject database shall contain at least 25 male and 25 female subjects and all above 18 years old.

3. Test procedures:

   1. Record the name, age, gender, and height of each subject.
   2. Let subject seated calmly for two minutes before test, dry the feet.
   3. Use device to measure weight, body fat, total body water, bone mass, and muscle mass; record reading value.
   4. For each subject, repeat 3) to get 3 pairs measurements.
   5. Repeat step 1) to 4) for every device (DUT: GBF-1251-B, BF-1255-B, BF-1256-B, and GBF-1257-B; and reference device: GBF-950-D).
   6. Repeat step 1) to 5) for each subject.

4. Note:

   1. No motion and speaking are allowed during the measurement.
   2. All DUT use the same algorithms and contact the patient at the same body locations (feet), and operate on the same frequency.
   3. Test environment: Temperature: 22±1℃; Relative humidity: 40~70%.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Wuhou District Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• male,female

Exclusion Criteria:

• below 18 years old

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transtek 125X; Which measured by DUT (Transtek 125X): GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B.	Device: Transtek 125X; Measuring weight, total body water, body fat, muscle mass, and bone mass. Measure each participants by Transtek 125X (GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B).; Device: Transtek 950D; Measuring weight, total body water, body fat, muscle mass, and bone mass. Measure each participants by Transtek 950D (GBF-950-D).
Experimental: Transtek 950D; Measured by Reference (Transtek 950D): GBF-950-D.	Device: Transtek 125X; Measuring weight, total body water, body fat, muscle mass, and bone mass. Measure each participants by Transtek 125X (GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B).; Device: Transtek 950D; Measuring weight, total body water, body fat, muscle mass, and bone mass. Measure each participants by Transtek 950D (GBF-950-D).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI (Body Mass Index)	Body Fat, Total Body Water, Muscle Mass, Bone Mass	5 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Body Weight	5 Days

Collaborators and Investigators

• Sponsor: Leo Wang
• Collaborators: West China Hospital
• Investigators: Principal Investigator: Guoqing Li, Director, Wuhou District Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: January 5, 2013
• First Submitted That Met QC Criteria: January 7, 2013
• First Posted (Estimate): January 9, 2013

Study Record Updates

• Last Update Posted (Estimate): January 9, 2013
• Last Update Submitted That Met QC Criteria: January 7, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: muscle mass; bone mass; weight; total body water; body fat
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: 13001_Body Scale; BTS13001 (Other Identifier: BTSInternational)